LymphomaPhase 4NCT06026995
Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells
A Phase 4 study testing PEG-rhG-CSF and RhG-CSF in people with Lymphoma, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- PEG-rhG-CSF and RhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old, regardless of sex;
- Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
- KPS score ≥70;
- creatinine clearance rate ≥ 50mL/min, total bilirubin level < 1.5mg/dL, ALT and AST < 2 times the upper limit of normal value;
- Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
- Patients can tolerate chemotherapy;
Show all 9Show fewer
- No active infection before chemotherapy;
- The patient voluntarily participated in this trial and signed the informed consent form;
- The researcher thinks that the subjects can benefit.
Who cannot join
- Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
- Serious or uncontrolled virus infection: HIV, syphilis positive;
- Severe dysfunction of internal organs;
- severe mental or nervous system diseases;
- allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
- pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
- The researcher judges other subjects who are not suitable to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yao Liu, 13228684685, 64823926@qq.com
About this study
Official title: Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.
- Conditions
- Lymphoma
- Being tested
- PEG-rhG-CSF, RhG-CSF
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Subcutaneous injection with a fixed dose of 12 mg
RhG-CSFDrug
Inject rhG-CSF 5-10 μg/kg subcutaneously every day
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: PEG-rhG-CSF |
| control group | Active comparator | Not described Receives: Drug: RhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with CD34+ cells ≥2×106/kg
The proportion of patients with CD34+ cells ≥2×106/kg
Measured: 28 days
Secondary outcomes (5)
CD34+cell count
CD34+cell count
Measured: 28 days
Acquisition times
The number of times a patient needs to collect a sufficient number of CD34+ cells
Measured: 28 days
Mobilization time
Time interval from mobilization to collection
Measured: 28 days
Hematopoietic reconstruction time after transplantation
Hematopoietic reconstruction time after transplantation
Measured: 3 months
complication
complication
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Mar 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yao Liu, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026995
- Sponsor's protocol ID
- CSPC-JYL-PBSCT-02
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06026995
- Acronym / sponsor ID
- CSPC-JYL-PBSCT-02
- Conditions
- Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: PEG-rhG-CSF |
| control group | Active comparator | Drug: RhG-CSF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-65 years old, regardless of sex;
- Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
- KPS score ≥70;
- creatinine clearance rate ≥ 50mL/min, total bilirubin level < 1.5mg/dL, ALT and AST < 2 times the upper limit of normal value;
- Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
Key exclusion criteria (7 listed)
- Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
- Serious or uncontrolled virus infection: HIV, syphilis positive;
- Severe dysfunction of internal organs;
- severe mental or nervous system diseases;
- allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-rhG-CSFSubcutaneous injection with a fixed dose of 12 mg | Drug | experimental group |
| RhG-CSFInject rhG-CSF 5-10 μg/kg subcutaneously every day | Drug | control group |
Primary outcome
The proportion of patients with CD34+ cells ≥2×106/kg
Time frame: 28 days
The proportion of patients with CD34+ cells ≥2×106/kg
5 secondary outcomes
CD34+cell count
Time frame: 28 days
Acquisition times
Time frame: 28 days
Mobilization time
Time frame: 28 days
Hematopoietic reconstruction time after transplantation
Time frame: 3 months
complication
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-rhG-CSF and RhG-CSF in people with Lymphoma, run by Chongqing University Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Liu, doctor (132 2868 4685, 64823926@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with CD34+ cells ≥2×106/kg (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.